HRP20140818T1 - Pharmaceutical aerosol formulations of formoterol and beclometasone dipropionate - Google Patents

Pharmaceutical aerosol formulations of formoterol and beclometasone dipropionate Download PDF

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Publication number
HRP20140818T1
HRP20140818T1 HRP20140818AT HRP20140818T HRP20140818T1 HR P20140818 T1 HRP20140818 T1 HR P20140818T1 HR P20140818A T HRP20140818A T HR P20140818AT HR P20140818 T HRP20140818 T HR P20140818T HR P20140818 T1 HRP20140818 T1 HR P20140818T1
Authority
HR
Croatia
Prior art keywords
formulation
inhaler
formoterol
dipropionate
compressed
Prior art date
Application number
HRP20140818AT
Other languages
Croatian (hr)
Inventor
Gaetano Brambilla
Original Assignee
Chiesi Farmaceutici S.P.A.
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
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First worldwide family litigation filed litigation Critical https://patents.darts-ip.com/?family=42035850&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=HRP20140818(T1) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Application filed by Chiesi Farmaceutici S.P.A. filed Critical Chiesi Farmaceutici S.P.A.
Publication of HRP20140818T1 publication Critical patent/HRP20140818T1/en

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Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/0012Galenical forms characterised by the site of application
    • A61K9/007Pulmonary tract; Aromatherapy
    • A61K9/0073Sprays or powders for inhalation; Aerolised or nebulised preparations generated by other means than thermal energy
    • A61K9/008Sprays or powders for inhalation; Aerolised or nebulised preparations generated by other means than thermal energy comprising drug dissolved or suspended in liquid propellant for inhalation via a pressurized metered dose inhaler [MDI]
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/16Amides, e.g. hydroxamic acids
    • A61K31/165Amides, e.g. hydroxamic acids having aromatic rings, e.g. colchicine, atenolol, progabide
    • A61K31/167Amides, e.g. hydroxamic acids having aromatic rings, e.g. colchicine, atenolol, progabide having the nitrogen of a carboxamide group directly attached to the aromatic ring, e.g. lidocaine, paracetamol
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/33Heterocyclic compounds
    • A61K31/395Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/535Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with at least one nitrogen and one oxygen as the ring hetero atoms, e.g. 1,2-oxazines
    • A61K31/537Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with at least one nitrogen and one oxygen as the ring hetero atoms, e.g. 1,2-oxazines spiro-condensed or forming part of bridged ring systems
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/56Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids
    • A61K31/57Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids substituted in position 17 beta by a chain of two carbon atoms, e.g. pregnane or progesterone
    • A61K31/573Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids substituted in position 17 beta by a chain of two carbon atoms, e.g. pregnane or progesterone substituted in position 21, e.g. cortisone, dexamethasone, prednisone or aldosterone
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K45/00Medicinal preparations containing active ingredients not provided for in groups A61K31/00 - A61K41/00
    • A61K45/06Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/10Dispersions; Emulsions
    • A61K9/12Aerosols; Foams
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P11/00Drugs for disorders of the respiratory system
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P11/00Drugs for disorders of the respiratory system
    • A61P11/06Antiasthmatics
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P29/00Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K2300/00Mixtures or combinations of active ingredients, wherein at least one active ingredient is fully defined in groups A61K31/00 - A61K41/00

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  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Public Health (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Veterinary Medicine (AREA)
  • Animal Behavior & Ethology (AREA)
  • Epidemiology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Engineering & Computer Science (AREA)
  • Pulmonology (AREA)
  • Pain & Pain Management (AREA)
  • Organic Chemistry (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Otolaryngology (AREA)
  • General Chemical & Material Sciences (AREA)
  • Dispersion Chemistry (AREA)
  • Rheumatology (AREA)
  • Medicinal Preparation (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)

Claims (12)

1. Farmaceutska aerosolna formulacija za upotrebu kao stlačeni inahalat u inhalatoru koja sadrži sljedeće: (a) od 0.001 do 0.05% w/w formoterol-fumarat dihidrata, (b) od 0.05 do 0.16% w/w beklometazon-dipropionata, (c) od 2.0 do 4.8% w/w etanola; (d) HFA 134a; naznačena time da je 1,1,1,2-tetrafluoretan jedini propelant te da je formoterol-fumarat dihidrat suspendiran u formulaciju usitnjenom obliku, dok je beklometazon-dipropionat potpuno otopljen.1. A pharmaceutical aerosol formulation for use as a compressed inhaler in an inhaler containing the following: (a) from 0.001 to 0.05% w/w formoterol fumarate dihydrate, (b) from 0.05 to 0.16% w/w beclomethasone dipropionate, (c) from 2.0 to 4.8% w/w ethanol; (d) HFA 134a; characterized by the fact that 1,1,1,2-tetrafluoroethane is the only propellant and that formoterol-fumarate dihydrate is suspended in the formulation in a powdered form, while beclomethasone-dipropionate is completely dissolved. 2. Formulacija kako je prijavljena u patentnom zahtjevu 1, naznačena time da kao aktivne sastojke sadrži samo kombinaciju formoterol-fumarata i beklometazon-dipropionata.2. The formulation as reported in patent claim 1, characterized by the fact that it contains only the combination of formoterol fumarate and beclomethasone dipropionate as active ingredients. 3. Formulacija kako je prijavljena u patentnom zahtjevu 1 ili 2, naznačena time da je sadržaj etanola između 2.5 i 4.5 w/w.3. The formulation as claimed in claim 1 or 2, characterized in that the ethanol content is between 2.5 and 4.5 w/w. 4. Formulacija kako je prijavljena u patentnom zahtjevu 3, naznačena time da rečeni sadržaj jest između 2.5% i 4.0% w/w.4. The formulation as claimed in claim 3, wherein said content is between 2.5% and 4.0% w/w. 5. Inhalator sa stlačenim inhalatom, naznačen time da sadrži spremnik napunjen farmaceutskom aerosolnom formulacijom iz bilo kojeg od patentnih zahtjeva 1 do 4, te odmjerni ventil za isporuku terapijski učinkovitih doza aktivnih tvari.5. An inhaler with a compressed inhalation, characterized in that it contains a container filled with a pharmaceutical aerosol formulation from any of claims 1 to 4, and a metering valve for delivering therapeutically effective doses of active substances. 6. Inhalator sa stlačenim inhalatom kako je prijavljen u patentnom zahtjevu 5, naznačen time da je doza formoterol-fumarata 6 ili 12 mg.6. An inhaler with a compressed inhaler as reported in patent claim 5, characterized in that the dose of formoterol fumarate is 6 or 12 mg. 7. Inhalator sa stlačenim inhalatom kako je prijavljen u patentnom zahtjevu 5 ili 6, naznačen time da je doza beklametazon-dipropionata 550 ili 100 mg.7. An inhaler with a compressed inhaler as reported in claim 5 or 6, characterized in that the dose of beclamethasone dipropionate is 550 or 100 mg. 8. Farmaceutska aerosolna formulacija iz bilo kojeg od patentnih zahtjeva 1 do 4, naznačena time da je za prevenciju i/ili liječenje blagih, umjerenih ili ozbiljnih akutnih ili kroničnih simptoma ili za profilaktičko liječenje respiratornih bolesti.8. Pharmaceutical aerosol formulation from any one of patent claims 1 to 4, characterized in that it is for the prevention and/or treatment of mild, moderate or severe acute or chronic symptoms or for the prophylactic treatment of respiratory diseases. 9. Formulacija prema patentnom zahtjevu 8, naznačena time da bolest jest astma ili kronična opstruktivna bolest pluća.9. Formulation according to claim 8, characterized in that the disease is asthma or chronic obstructive pulmonary disease. 10. Upotreba kortikosteroida za aerosolnu formulaciju za inhalaciju, naznačena time da formulacija kao aktivnu tvar sadrži farmaceutsko prihvatljivu sol ili solvat formoterola te smjesu HFA134 i etanola kao vezikula za smanjivanje topljivosti rečene soli formoterola u rečenom vezikulu, pri čemu je polarnost vezikula, izražena kao dielektričnom konstantom εm, između 9.5 i 11.0.10. The use of corticosteroids for an aerosol formulation for inhalation, characterized by the fact that the formulation as an active substance contains a pharmaceutically acceptable salt or solvate of formoterol and a mixture of HFA134 and ethanol as a vesicle to reduce the solubility of said formoterol salt in said vesicle, wherein the polarity of the vesicle, expressed as a dielectric constant εm, between 9.5 and 11.0. 11. Upotreba prema patentnom zahtjevu 10, naznačena time da je kortikosteroid odabran iz sljedeće skupine: beklometazon-dipropionat i odgovarajući solvati, budezoni i njegovi epimeri, flutikazon i njegovi esteri, mometazon-fluorat, flunizolid i ciklezonid.11. Use according to patent claim 10, characterized in that the corticosteroid is selected from the following group: beclometasone-dipropionate and corresponding solvates, budesones and its epimers, fluticasone and its esters, mometasone-fluorate, flunizolid and ciclesonide. 12. Upotreba prema patentnom zahtjevu 11, naznačena time da kortikosteroid jest beklometazon-dipropionat.12. Use according to claim 11, characterized in that the corticosteroid is beclomethasone dipropionate.
HRP20140818AT 2009-10-02 2014-09-01 Pharmaceutical aerosol formulations of formoterol and beclometasone dipropionate HRP20140818T1 (en)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
EP09172083 2009-10-02
PCT/EP2010/005879 WO2011038872A1 (en) 2009-10-02 2010-09-27 Pharmaceutical aerosol formulations of formoterol and beclometasone dipropionate

Publications (1)

Publication Number Publication Date
HRP20140818T1 true HRP20140818T1 (en) 2014-10-10

Family

ID=42035850

Family Applications (2)

Application Number Title Priority Date Filing Date
HRP20140818AT HRP20140818T1 (en) 2009-10-02 2014-09-01 Pharmaceutical aerosol formulations of formoterol and beclometasone dipropionate
HRP20160630TT HRP20160630T1 (en) 2009-10-02 2016-06-08 Pharmaceutical aerosol formulations of formoterol and beclometasone dipropionate

Family Applications After (1)

Application Number Title Priority Date Filing Date
HRP20160630TT HRP20160630T1 (en) 2009-10-02 2016-06-08 Pharmaceutical aerosol formulations of formoterol and beclometasone dipropionate

Country Status (22)

Country Link
US (1) US8420060B2 (en)
EP (2) EP2727582B1 (en)
KR (1) KR101778814B1 (en)
CN (2) CN102548537B (en)
AR (2) AR078494A1 (en)
BR (1) BR112012007484A2 (en)
CA (1) CA2776266C (en)
CY (2) CY1115266T1 (en)
DK (2) DK2727582T3 (en)
ES (2) ES2487626T3 (en)
HK (2) HK1167817A1 (en)
HR (2) HRP20140818T1 (en)
HU (1) HUE029159T2 (en)
JO (1) JO3024B1 (en)
ME (1) ME02398B (en)
PL (2) PL2482799T3 (en)
PT (1) PT2482799E (en)
RS (2) RS54721B1 (en)
RU (1) RU2650175C2 (en)
SI (2) SI2727582T1 (en)
TW (1) TWI449523B (en)
WO (1) WO2011038872A1 (en)

Families Citing this family (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US9119777B2 (en) * 2008-05-30 2015-09-01 Microdose Therapeutx, Inc. Methods and compositions for administration of oxybutynin
LT2806855T (en) * 2012-01-25 2018-10-10 Chiesi Farmaceutici S.P.A. Dry powder formulation comprising a corticosteroid and a beta-adrenergic for administration by inhalation
US11052202B2 (en) * 2012-11-07 2021-07-06 Chiesi Farmaceutici S.P.A. Drug delivery device for the treatment of patients with respiratory diseases
CN108289843B (en) 2015-12-04 2021-08-17 墨西哥氟石股份公司 Pharmaceutical composition
CN112438966B (en) * 2019-08-30 2022-08-26 四川普锐特药业有限公司 Medical quantitative inhalation aerosol

Family Cites Families (12)

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US5290539A (en) 1990-12-21 1994-03-01 Minnesota Mining And Manufacturing Company Device for delivering an aerosol
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RU2356537C2 (en) * 2007-07-25 2009-05-27 Закрытое Акционерное Общество (ЗАО) "Пульмомед" Pharmaceutical composition of metered aerosols containing antiasthmatic agents in form of suspensions, solutions, emulsions, solutions and emulsions

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Publication number Publication date
CA2776266C (en) 2017-11-28
CN103919785A (en) 2014-07-16
CY1117596T1 (en) 2017-04-26
CY1115266T1 (en) 2017-01-04
DK2482799T3 (en) 2014-09-01
EP2482799B1 (en) 2014-06-18
RS53514B1 (en) 2015-02-27
ES2568913T3 (en) 2016-05-05
US20110081301A1 (en) 2011-04-07
HRP20160630T1 (en) 2016-07-01
PL2727582T3 (en) 2016-06-30
RS54721B1 (en) 2016-08-31
PT2482799E (en) 2014-08-06
RU2650175C2 (en) 2018-04-10
CA2776266A1 (en) 2011-04-07
ES2487626T3 (en) 2014-08-22
ME02398B (en) 2016-09-20
EP2727582A1 (en) 2014-05-07
KR101778814B1 (en) 2017-09-15
WO2011038872A1 (en) 2011-04-07
SI2482799T1 (en) 2014-10-30
KR20120100901A (en) 2012-09-12
TWI449523B (en) 2014-08-21
AR123674A2 (en) 2023-01-04
DK2727582T3 (en) 2016-05-17
EP2482799A1 (en) 2012-08-08
AR078494A1 (en) 2011-11-09
CN103919785B (en) 2016-08-24
EP2727582B1 (en) 2016-03-16
HK1167817A1 (en) 2012-12-14
JO3024B1 (en) 2016-09-05
TW201119644A (en) 2011-06-16
PL2482799T3 (en) 2014-11-28
BR112012007484A2 (en) 2020-06-09
US8420060B2 (en) 2013-04-16
SI2727582T1 (en) 2016-05-31
HUE029159T2 (en) 2017-02-28
CN102548537B (en) 2014-06-25
CN102548537A (en) 2012-07-04
RU2012112454A (en) 2013-11-10
HK1199214A1 (en) 2015-06-26

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